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The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.

The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
• Abutment design software: 3Shape Abutment Designer Software (K151455)
• Milling machine: Roland DWX51D Milling Machine

The provided text describes the TIB Abutment System and its performance data to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a study with specific performance metrics.

Therefore, I cannot populate the table or answer questions 2 through 7 directly from the provided text as the document does not present acceptance criteria in a quantitative format, nor does it detail a standalone study with performance metrics for the TIB Abutment System against such criteria. Instead, it relies on comparative equivalence with already cleared devices and various non-clinical tests.

However, I can extract information related to the performance data and ground truth establishment that were conducted as part of the substantial equivalence demonstration.

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" for the TIB Abutment System in a format that would fit a table like the one requested. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons. The performance data listed are primarily compliance tests against recognized standards rather than specific device performance metrics against predefined thresholds.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests mentioned. It only lists the types of tests performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. The document refers to non-clinical tests and compliance with standards, not expert-adjudicated ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The document refers to non-clinical tests and compliance with standards, not expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a dental abutment system, not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document describes non-clinical testing of the device components and workflow, which can be considered a form of standalone evaluation for the device itself. The types of standalone tests performed include:

• Biocompatibility testing per ISO 10993-1 and ISO 10993-5.
• Validated sterilization instructions per ISO 17665-2.
• Software validation testing per FDA Guidance.
• Scanning and milling validation.
• Static and dynamic compression-bending to ISO 14801.
• Mechanical ISO 14801 Fatigue Testing for implant platforms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context is established by adherence to recognized international standards and FDA guidance documents for medical device testing. For example:

• Biocompatibility: ISO 10993-1 and ISO 10993-5 standards.
• Sterilization: ISO 17665-2.
• Software Validation: FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
• Mechanical Testing: ISO 14801.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dental abutment system) and its non-clinical testing for substantial equivalence, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a machine learning model mentioned.

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